Back to results

The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 2

Locations

Poland

Study Type

Interventional

Intervention

AZD8683, 50 mcg

Placebo

AZD8683, 200 mcg

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic Obstructive Pulmonary Disease (COPD), safety, inhalation, long-acting muscarinic receptor antagonist (LAMA)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of COPD
Current or ex-smokers
FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC < 70%

Exclusion Criteria:

Any clinically significant disease or disorder
Any clinically relevant abnormal findings at screening examinations
Family history or presence of glaucoma
Need of long term oxygen therapy

Sites / Locations

Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

First 50 mcg, then 200 mcg, then placebo

First 50 mcg, then placebo, then 200 mcg

First 200 mcg, then placebo, then 50 mcg

First 200 mcg, then 50 mcg, then placebo

First placebo, then 200 mcg, then 50 mcg

First placebo, then 50 mcg, then 200 mcg

Arm Description

period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo

period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg

period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg

period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo

period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg

period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg

Outcomes

Primary Outcome Measures

Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose

Maximum FEV1 value

Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose

Trough FEV1 value

Secondary Outcome Measures

Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose

Average FEV1 value

Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose

Maximum FVC value

Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose

Average systolic blood pressure value

Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose

Average diastolic blood pressure value

Pulse, Average Effect Over 0 - 4 Hours Post-dose

Average pulse value

Heart Rate, Average Effect Over 0 - 4 Hours Post-dose

Average heart rate value

QTcF, Average Effect Over 0 - 4 Hours Post-dose

Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula

Plasma AZD8683 Cmax

Maximum plasma concentration of AZD8683

Plasma AZD8683 AUC0-24

Area under the AZD8683 plasma concentration curve from 0 to 24 hours

Full Information

NCT ID

NCT01205269

First Posted

September 15, 2010

Last Updated

February 24, 2014

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01205269

Brief Title

The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Official Title

A Double-blind, Placebo-controlled, Randomised, Multi-centre, 3-way Cross-over, Single-dose Phase II Study to Investigate the Local and Systemic Effects of Inhaled AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.

Detailed Description

A double-blind, placebo-controlled, randomised, multi-centre, 3-way cross-over, single-dose phase II study to investigate the local and systemic effects of inhaled AZD8683 in patients with chronic obstructive pulmonary disease (COPD)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease (COPD), safety, inhalation, long-acting muscarinic receptor antagonist (LAMA)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

First 50 mcg, then 200 mcg, then placebo

Arm Type

Experimental

Arm Description

period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo

Arm Title

First 50 mcg, then placebo, then 200 mcg

Arm Type

Experimental

Arm Description

period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg

Arm Title

First 200 mcg, then placebo, then 50 mcg

Arm Type

Experimental

Arm Description

period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg

Arm Title

First 200 mcg, then 50 mcg, then placebo

Arm Type

Experimental

Arm Description

period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo

Arm Title

First placebo, then 200 mcg, then 50 mcg

Arm Type

Experimental

Arm Description

period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg

Arm Title

First placebo, then 50 mcg, then 200 mcg

Arm Type

Experimental

Arm Description

period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg

Intervention Type

Drug

Intervention Name(s)

AZD8683, 50 mcg

Intervention Description

Dry powder for inhalation, single dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Dry powder for inhalation, single dose

Intervention Type

Drug

Intervention Name(s)

AZD8683, 200 mcg

Intervention Description

Dry powder for inhalation, single dose

Primary Outcome Measure Information:

Title

Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose

Description

Maximum FEV1 value

Time Frame

0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h

Title

Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose

Description

Trough FEV1 value

Time Frame

22 h, 24 h, 26 h

Secondary Outcome Measure Information:

Title

Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose

Description

Average FEV1 value

Time Frame

0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h

Title

Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose

Description

Maximum FVC value

Time Frame

0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h

Title

Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose

Description

Average systolic blood pressure value

Time Frame

0, 30 min, 2 h, 4 h

Title

Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose

Description

Average diastolic blood pressure value

Time Frame

0, 30 min, 2 h, 4 h

Title

Pulse, Average Effect Over 0 - 4 Hours Post-dose

Description

Average pulse value

Time Frame

0, 30 min, 2 h, 4 h

Title

Heart Rate, Average Effect Over 0 - 4 Hours Post-dose

Description

Average heart rate value

Time Frame

0, 30 min, 2 h, 4 h

Title

QTcF, Average Effect Over 0 - 4 Hours Post-dose

Description

Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula

Time Frame

0, 30 min, 2 h, 4 h

Title

Plasma AZD8683 Cmax

Description

Maximum plasma concentration of AZD8683

Time Frame

0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h

Title

Plasma AZD8683 AUC0-24

Description

Area under the AZD8683 plasma concentration curve from 0 to 24 hours

Time Frame

0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of COPD Current or ex-smokers FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC < 70% Exclusion Criteria: Any clinically significant disease or disorder Any clinically relevant abnormal findings at screening examinations Family history or presence of glaucoma Need of long term oxygen therapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Piotr Kuna, MD Professor

Organizational Affiliation

Poland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Białystok

Country

Poland

Facility Name

Research Site

City

Bydgoszcz

Country

Poland

Facility Name

Research Site

City

Proszowice

Country

Poland

Facility Name

Research Site

City

Łódź

Country

Poland

12. IPD Sharing Statement

Learn more about this trial

The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

We'll reach out to this number within 24 hrs